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Lung Diseases clinical trials

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NCT ID: NCT02130635 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Dose-Response Relationship of Multiple Doses of GSK2269557 Administered as a Dry Powder to Chronic Obstructive Pulmonary Disease (COPD) Patients

Start date: July 31, 2014
Phase: Phase 2
Study type: Interventional

This is a randomised, double-blind, placebo controlled, parallel group study to evaluate the safety, tolerability, pharmacokinetics and dose response of multiple doses of GSK2269557 administered as a dry powder in COPD subjects. Pharmacodynamic effects on biomarkers will also be assessed. This study will have two parts. In Part A, subjects will be randomized to active or placebo treatment in a 3:1 ratio and in Part B, to placebo or one of the six doses of active treatment in an equal ratio. A sufficient number of COPD subjects (male and female of non-child bearing potential) will be screened to ensure that approximately 30 subjects are enrolled and at least 20 evaluable subjects are obtained for Part A and approximately 35 subjects will be enrolled for Part B. In both the parts, subjects will receive study treatment once daily for 14 consecutive days. Placebo control will be included for a valid evaluation of adverse events attributable to treatment versus those independent of treatment.

NCT ID: NCT02130193 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Investigation of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of Oral Danirixin in Symptomatic COPD Subjects With Mild to Moderate Airflow Limitation at Risk for Exacerbations

Start date: February 2014
Phase: Phase 2
Study type: Interventional

The aim of this First Time in Patient study is to obtain initial information on the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of repeat daily administration of danirixin in subjects with symptomatic chronic obstructive pulmonary disease (COPD) having mild to moderate airflow limitation and are at high risk for future COPD exacerbations. The study will be conducted in two parts. Part A will be a two week open label, single arm study in patients with COPD to obtain pharmacokinetic data and safety information of repeat dosing of danirixin in the population of interest. Approximately 10 subjects will be enrolled in Part A of the study. Progression to and dose selection for Part B will occur following review of the data collected in Part A. Part B will be a 52-week, randomized, double-blind (sponsor unblind), placebo-controlled on top of standard of care, parallel group study. Part B will evaluate several clinical efficacy assessments related to exacerbations and respiratory symptoms. Approximately 100 subjects will be enrolled with a target of 80 subjects completing 52 weeks of danirixin administration.

NCT ID: NCT02128529 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Epidemiology of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Start date: October 2010
Phase: N/A
Study type: Observational

The purpose of this study was to investigate the prevalence of chronic bronchitis in patients suffering from moderate to very severe chronic obstructive pulmonary disease (COPD), and to assess the difference in exacerbation rates in patients suffering from moderate to very severe COPD with chronic bronchitis vs. a population of patients without chronic bronchitis.

NCT ID: NCT02125916 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Evaluating the Effect of Oxygentherapy on Concentration at Chronic Lung Patients

Start date: July 2014
Phase: N/A
Study type: Interventional

The objective is to study the cognitive functions in patients with chronic obstructive lung disease (COLD) and patients with interstitial lung disease (ILD) compared to healthy controls. The cognitive functions are tested with and without oxygen therapy to clarify the effect of oxygen therapy. Driving simulations is used to test the cognitive functions. The hypothesis is that patients with chronic lung disease have decreased cognitive functions and that oxygen therapy will increase their cognitive functions.

NCT ID: NCT02125734 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients

FAVOR
Start date: April 2014
Phase: Phase 4
Study type: Interventional

The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung function. Similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at screening despite being treated with tiotropium

NCT ID: NCT02123030 Completed - Lung Cancer Clinical Trials

A Micro/Nano Device for Exhaled Breath Analysis

Start date: November 7, 2012
Phase:
Study type: Observational

Use of a microfabricated silicon device to concentrate ultra trace volatile organic compounds (VOCs) in human exhaled breath for quantitative analysis of VOCs.

NCT ID: NCT02122614 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Home-monitoring and Adherence of Patients With COPD to Long-term Rehabilitation

Start date: April 2014
Phase: N/A
Study type: Interventional

The aim of this randomized controlled trial is to investigate the effects of adding PA monitoring and regular feedback of a pedometer (step counter) to an outpatient pulmonary rehabilitation (PR) program on daily PA levels and health status of patients with COPD. Patients will be randomized to either receive a PR program with PA monitoring and regular feedback of a pedometer (experimental group [EG]) or a PR program alone (control group [CG]). During the PR program, patients in the EG will receive a pedometer to self-monitor their PA and individualized step-count goals. They will continue to use the pedometers and receive individualized goals for 3 months after the program. It is expected that, by receiving individualized goals and a simple pedometer to self-monitor their PA during and after a PR program, patients with COPD will become more active and adhere to long-term rehabilitation, thus reducing the overall impact of COPD.

NCT ID: NCT02119494 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Phenotypes of COPD in Central and Eastern Europe

POPE
Start date: June 2014
Phase: N/A
Study type: Observational [Patient Registry]

The purpose of this study is to assess the representation of COPD patients in terms of categories and phenotypes of the disease in selected countries in Central and Eastern Europe (CEE). The results of The POPE study will allow for evaluation of the differences in clinical approaches and treatment practices. The following countries are represented in The POPE study: Czech Republic, Slovakia, Austria, Poland, Hungary, Russia, Croatia, Serbia, Slovenia, Estonia, Latvia and Bulgaria.

NCT ID: NCT02119286 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD) -Study 2

Start date: October 2013
Phase: Phase 3
Study type: Interventional

After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.

NCT ID: NCT02114567 Completed - Clinical trials for Acute Exacerbation Chronic Obstructive Pulmonary Disease

Is it Necessary to Set External PEEP in AECOPD Patients

Start date: January 2014
Phase: N/A
Study type: Interventional

Acute exacerbation of chronic obstructive pulmonary disease patients with intrinsic positive end-expiratory pressure (PEEPi), Neurally adjusted ventilatory assist (NAVA) reduce work of breathing and trigger delay at any external positive end-expiratory pressure (PEEPe) level compared with pressure-support ventilation (PSV)